Preventing cognitive decline in older African Americans with mild cognitive impairment: Design and methods of a randomized clinical trial
Open accessAbstract
Mild Cognitive Impairment (MCI) affects 25% of older African Americans and predicts progression to Alzheimer's disease. An extensive epidemiologic literature suggests that cognitive, physical, and/or social activities may prevent cognitive decline. We describe the methods of a randomized clinical trial to test the efficacy of Behavior Activation to prevent cognitive decline in older African Americans with the amnestic multiple domain subtype of MCI. Community Health Workers deliver 6 initial in-home treatment sessions over 2-3 months and then 6 subsequent in-home booster sessions using language, materials, and concepts that are culturally relevant to older African Americans during this 24 month clinical trial. We are randomizing 200 subjects who are recruited from churches, senior centers, and medical clinics to Behavior Activation or Supportive Therapy, which controls for attention. The primary outcome is episodic memory as measured by the Hopkins Verbal Learning Test-Revised at baseline and at months 3, 12, 18, and 24. The secondary outcomes are general and domain-specific neuropsychological function, activities of daily living, depression, and quality-of-life. The negative results of recent clinical trials of drug treatments for MCI and Alzheimer's disease suggest that behavioral interventions may provide an alternative treatment approach to preserve cognition in an aging society.
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With regard to mood, well-being and quality of life, no therapeutic effects in MCI patients, neither at short-term (3 months) nor at long-term (24 months) follow-up, were detected in most studies, including four randomized controlled trials and one randomized non-controlled trial.
“With regard to mood, well-being and quality of life no therapeutic effects in MCI patients, neither at short-term (3 months) nor at long-term (24 months) follow-up, were detected in most studies, including four randomized controlled trials [48–51, 54, 59, 60] and one randomized non-controlled trial [52, 53].”
From Psychotherapeutic interventions in individuals at risk for Alzheimer’s dementia: a systematic review (2022) · cites this paper as [48]
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Experimental — accuracy not yet measuredLong-term follow-up assessments (6 or more months post-intervention) were described in 14 publications.
“Long-term follow-up assessments (6 or more months post-intervention) were described in 14 publications [37, 39, 43, 48, 49, 51–53, 59, 60, 62, 63, 68, 69].”
From Psychotherapeutic interventions in individuals at risk for Alzheimer’s dementia: a systematic review (2022) · cites this paper as [48]
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Identifying and substantiating the need for interventions
Gitlin, L. N., & Czaja, S. J. (2025) · Elsevier eBooks · doi:10.1016/b978-0-443-21664-0.00029-5
- Authors
- Rovner, B. W., Casten, R. J., Hegel, M. T., & Leiby, B. E.
- Affiliations
- Jefferson Hospital for Neuroscience (US)
- Dartmouth–Hitchcock Medical Center (US)
- Thomas Jefferson University (US)
- Corresponding author
- Rovner, Barry W.
- Venue
- Contemporary Clinical Trials
- Publisher
- Elsevier BV
- Published
- 2012-07
- Volume
- 33
- Issue
- 4
- Pages
- 712-720
- ISSN
- 1551-7144 (ISSN-L)
- PMC
- PMC3361551
- OpenAlex
- W1997076051
- Cited by
- 22
- References
- 109
- Citations by year
- 2025: 1 · 2023: 1 · 2022: 2 · 2020: 1 · 2019: 2 · 2018: 2 · 2017: 1 · 2016: 4 · 2015: 2 · 2014: 3 · 2013: 3
- FWCI
- 1.82
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- Contemporary Clinical Trials (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute on Aging (R01AG035025)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Cancer-related cognitive impairment studies
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Cognitive Functions and Memory
- Keywords
- mild cognitive impairment, cognitive decline prevention, behavioral activation, African American older adults, community health workers, home-based intervention, culturally sensitive interventions, episodic memory, amnestic MCI, Alzheimer's disease prevention, behavioral interventions, activities of daily living, depression, quality of life
- MeSH terms
- Activities of Daily Living, Aged, Aged, 80 and over, Alzheimer Disease, Behavior Therapy, Black or African American, Clinical Protocols, Depression, Humans, Psychological Tests, Quality of Life, Research Design, Linear Models, Treatment Outcome, Disease Progression, Intention to Treat Analysis, Cognitive Dysfunction
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